Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000361303
Ethics application status
Approved
Date submitted
17/06/2008
Date registered
25/07/2008
Date last updated
3/07/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Support for ongoing breastfeeding
Scientific title
The effect of trained General Practice Nurse
support for mothers on rates of exclusive
breastfeeding and ongoing breastfeeding.
Secondary ID [1] 593 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Short duration of any breastfeeding 3273 0
Short duration of exclusive breastfeeding 3274 0
Condition category
Condition code
Diet and Nutrition 3437 3437 0 0
Other diet and nutrition disorders
Public Health 295774 295774 0 0
Health promotion/education
Reproductive Health and Childbirth 295775 295775 0 0
Breast feeding

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of Conversation Tool by Practice Nurse, to guide structured motivational interaction with breastfeeding mother at each routine preventive health visits for child immunisation at 2, 4 and 6 months of age. Routine visits take 10-30 minutes and the intervention may take 5-20 minutes dependent on pragmatic factors and mothers' issues, with the total visit anticipated to last 15 - 30 minutes. The intervention will be trialled over a period of 18 months.
Intervention code [1] 3013 0
Behaviour
Intervention code [2] 292254 0
Lifestyle
Comparator / control treatment
Practice Nurses in the control General Practices will provide standard treatment at child immunisation visits. Usually this includes a general question on child health and wellbeing, and commonly includes directive advice regarding any breastfeeding concerns raised by mothers at the 2 month visit but generally no further discussion at subsequent visits unless initiated by the mother. Commonly practice nurses have limited knowledge of breastfeeding management or motivational interviewing skills.
Control group
Active

Outcomes
Primary outcome [1] 4330 0
any breastfeeding (rate) as assessed by telephone interview with mothers to determine feeding in the previous 24 hours and age at last breastfeeding if weaned.
Timepoint [1] 4330 0
3 and 6 months postpartum
Primary outcome [2] 4331 0
Exclusive breastfeeding (rate) as assessed by by telephone interview with mothers to determine feeding in the previous 24 hours according to World Health Organisation recommended quesitons, and age at introduction of solids if not exclusively breastfeeding.'
Timepoint [2] 4331 0
3 and 6 months postpartum
Secondary outcome [1] 315673 0
Practice nurse experience of delivering the intervention
Timepoint [1] 315673 0
repeated irregular contact points across the 18 months of the conduct of the trial

Eligibility
Key inclusion criteria
Breastfeeding at 8 weeks postpartum; planning to attend participating general practice for infant care
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to hold a conversation in English (primary language is other than English)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer of clusters, namely General Practice locations, to intervention or control, and hence of the women who attend those practices to intervention or control groups by cluster. Pregnant women are invited to participate by mailout from birthing hospitals, and allocated when they identify their usual general practice. Thus allocation was concealed at the time of randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple cluster randomisation by computer allocation of practices to intervention or control. Stratification by practice size, larger and smaller practices in each of two locations randomised separately. Size determined by number of infants as current patients.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Contolled trial with participants in the intervention group receiving a single intervention on up to 3 occasions at routine visits and participants in the control group receiving usual care at routine visits. All participants in the intervention group receive the same intervention, the Conversation Tool application.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/07/2008
Actual
17/07/2008
Date of last participant enrolment
Anticipated
Actual
27/10/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
278
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 975 0
2650
Recruitment postcode(s) [2] 976 0
2640
Recruitment postcode(s) [3] 977 0
2641
Recruitment postcode(s) [4] 978 0
3690

Funding & Sponsors
Funding source category [1] 3491 0
University
Name [1] 3491 0
University of New South Wales
Country [1] 3491 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Rural Clinical School
PO Box 5695
Wagga Wagga NSW 2650
Country
Australia
Secondary sponsor category [1] 3254 0
None
Name [1] 3254 0
Address [1] 3254 0
Country [1] 3254 0
Other collaborator category [1] 313 0
Individual
Name [1] 313 0
Professor Ellen McIntyre
Address [1] 313 0
Department of General Practice
Flinders University,
GPO Box 2100,
Adelaide SA 5001
Country [1] 313 0
Australia
Other collaborator category [2] 337 0
Individual
Name [2] 337 0
Professor Louis Pilotto
Address [2] 337 0
Rural Clinical School
PO Box 5695
Wagga Wagga NSW 2650
Country [2] 337 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5526 0
University of New South Wales Human Research Ethics
Ethics committee address [1] 5526 0
Ethics Secretariat,
UNSW Research Services
Rupert Myers Building, Level 3
The University of New South Wales NSW 2052
Ethics committee country [1] 5526 0
Australia
Date submitted for ethics approval [1] 5526 0
Approval date [1] 5526 0
09/11/2007
Ethics approval number [1] 5526 0
HREC 07246
Ethics committee name [2] 5527 0
Joint Hospitals Ethics Committee (EC00117)
Ethics committee address [2] 5527 0
Albury/Wodonga Joint Ethics Committee
PO Box 156
Wodonga VIC 3689
Ethics committee country [2] 5527 0
Australia
Date submitted for ethics approval [2] 5527 0
Approval date [2] 5527 0
18/06/2008
Ethics approval number [2] 5527 0
no number given
Ethics committee name [3] 5528 0
Greater Southern Area Health Service HREC (EC00121)
Ethics committee address [3] 5528 0
PO Box 3095
ALBURY NSW 2640
Ethics committee country [3] 5528 0
Australia
Date submitted for ethics approval [3] 5528 0
Approval date [3] 5528 0
14/07/2008
Ethics approval number [3] 5528 0
08/GSAHS/19

Summary
Brief summary
Health of mothers and infants would improve if breastfeeding rates were closer to the recommendations. Mothers' choices about how to feed their babies depend on information initially, motivation continually, and in the longer term, support. Support is most effective when provided by those skilled in breastfeeding management and good communication. This study proposes that proactive ongoing support from a known and trained primary health professional, namely the General Practice Nurse, using a motivational interviewing approach, can improve breastfeeding duration and delay introduction of solids or other foods.
Trial website
Trial related presentations / publications
Elliott-Rudder, M., Pilotto, L., McIntyre, E., Ramanathan, S., 2014 Motivational interviewing improves exclusive breastfeeding in an Australian randomised controlled trial, Acta Paediatrica, International Journal of Paediatrics
103 (1), pp. e11-e16 2014
Public notes

Contacts
Principal investigator
Name 28674 0
Dr Megan Elliott-Rudder
Address 28674 0
UNSW Rural Clinical School, Faculty of Medicine
PO Box 5695
Wagga Wagga NSW 2650
Country 28674 0
Australia
Phone 28674 0
+61 2 413 598775
Fax 28674 0
Email 28674 0
megan.elliottrudder@unswalumni.com
Contact person for public queries
Name 11831 0
Dr Megan Elliott-Rudder
Address 11831 0
Rural Clinical School, UNSW
PO Box 5695
Wagga Wagga NSW 2650
Country 11831 0
Australia
Phone 11831 0
02 6933 5205
Fax 11831 0
02 6933 5100
Email 11831 0
megan.elliottrudder@unswalumni.com
Contact person for scientific queries
Name 2759 0
Dr Megan Elliott-Rudder
Address 2759 0
Rural Clinical School, UNSW
PO Box 5695
Wagga Wagga NSW 2650
Country 2759 0
Australia
Phone 2759 0
02 6933 5205
Fax 2759 0
02 6933 5100
Email 2759 0
megan.elliottrudder@unswalumni.com

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